DeRoyal Sterile Custom kits containing Medline Aplicare Povidone… — Class II medical device recall Z-0199-2018
Terminated recall by DeRoyal Industries Inc, reported 2017-12-13, distributed nationwide. Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline In
| Recall number | Z-0199-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2017-10-16 |
| Classified | 2017-12-06 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 5,946 units |
| Reason classes | labeling |
| Lot numbers | 41684621, 41957423, 42054787, 42302605, 42623281, 42691241, 42699622, 42728139, 42812373, 42982612, 43183812, 43197966, 43253681, 43504920, 43638080, 43793400, 43959220, 43979458, 44094150, 44484561, 44508341, 44514919, 44543787, 44877040, 45017543, 45456132 |
| Model numbers | 47-763.04, 47-763.06, 47-763.07, 89-6752.01, 89-6818.02, 89-7212.04, 89-7212.05 |
Product
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f) Plastic Pack, REF 89-7212.04 g) Plastic Pack, REF 89-7212.05 Product Usage: Custom surgical and procedural kits
Reason for recall
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0199-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.